# K182943: VERTEX Nitinol Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, LLC
- Decided: Apr 4, 2019 after 163 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902307 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142111: Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis Staple, Novatsep (2014) Summary page 5.
- K011716: The Uni-Clip Staple, New Deal, S.A. (2001) Summary page 5.
- K142292: Speed, Speed Shift, Speed Titan, Speed Arc, Biomedical Enterprises, Inc. (2014) Summary page 5.

## Indications for use
The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.

Source page: https://510kreport.com/device/K182943
Methodology: https://510kreport.com/methodology